From CE to UKCA: Navigating the UK Medical Device Transition

This episode breaks down the essential steps for medical device manufacturers with a CE mark to comply with UK regulations for Great Britain. We cover the extended deadlines for CE mark recognition, the immediate requirements for MHRA registration and appointing a UK Responsible Person (UKRP), and the process for achieving UKCA conformity assessment. Learn the key dates and actions you need to take to ensure uninterrupted market access. Key Questions: • Is my CE mark still valid for selling medical devices in Great Britain? • What are the new deadlines for transitioning from CE to UKCA marking? • Do I need to switch to the UKCA mark immediately? • What is a UK Responsible Person (UKRP) and do I need one? • What is the first step I must take to place my device on the UK market? • How does the UKCA conformity assessment process differ from the CE marking process? • Are my existing CE technical files useful for the UKCA mark? • What are the specific labelling requirements for the UKCA mark? • Do the same rules apply to Northern Ireland? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.